0001438133FALSE00014381332023-11-012023-11-01


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

____________________________
FORM 8-K
____________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 1, 2023
____________________________
Tandem Diabetes Care, Inc.
(Exact name of registrant as specified in its charter)
____________________________
Delaware001-3618920-4327508
(State or other jurisdiction
of incorporation)		(Commission
File Number)		(I.R.S. Employer
 Identification No.)
12400 High Bluff Drive92130
San Diego California
(Zip Code)
(Address of principal executive offices)
Registrant’s telephone number, including area code: (858) 366-6900
N/A
(Former name or former address, if changed since last report)
____________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of Each ClassTrading SymbolName of Each Exchange on Which Registered
Common Stock, par value $0.001 per shareTNDMNASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
____________________________




Item 2.02 Results of Operations and Financial Condition.

On November 1, 2023, we issued a press release reporting our financial results for the quarter ended September 30, 2023. This press release has been furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.

The information under this Item 2.02 and Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 9.01 Financial Statements and Exhibits.
(d)     Exhibits.

 Number
Description
99.1
104Cover Page Interactive Data File (embedded within the Inline XBRL document).


2


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Tandem Diabetes Care, Inc.
By:/s/ SHANNON M. HANSEN
Shannon M. Hansen
Chief Legal, Privacy & Compliance Officer; Secretary
Date: November 1, 2023
3
Exhibit 99.1

tandemhorizontallogonewrgb.jpg
Media Contact:
858-255-6388
media@tandemdiabetes.com

Investor Contact:
858-366-6900
IR@tandemdiabetes.com


FOR IMMEDIATE RELEASE

Tandem Diabetes Care Announces Third Quarter 2023 Financial Results

San Diego, November 1, 2023 - Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter ended September 30, 2023 and updated its financial guidance for the year ending December 31, 2023.

Third Quarter and Recent Highlights

•Worldwide installed base increased 11 percent to approximately 444,000 in-warranty customers compared to the third quarter 2022.
•Published prospective study data demonstrating the immediate and sustained benefit of t:slim X2 with Control-IQ technology for one year across approximately 3,000 individuals living with type 1 diabetes.
•Commenced initial, limited release of Tandem Mobi in the United States.
•Reached the milestone of full U.S. healthcare provider availability of Tandem Source, our second-generation data management application.
•$498.2 million in cash, cash equivalents & short-term investments as of September 30, 2023.

“In this transitional year, we are focused on bringing the benefits of our #1 rated automated insulin delivery system to more people living with diabetes worldwide, providing customer care excellence and advancing our scalability initiatives,” said John Sheridan, president and chief executive officer. “There is a large and growing opportunity for Tandem’s technology to drive greater use of automated insulin delivery worldwide, and we are advancing our efforts to expand this adoption through our near-term portfolio of diabetes solutions.”
1
Exhibit 99.1
Third Quarter 2023 Financial Results Compared to 2022

In September 2022, the Company began offering the Tandem Choice Program (Tandem Choice) to eligible t:slim X2 customers to provide a pathway to ownership of its newest hardware platform, Tandem Mobi, for a fee when available. As a result of this program, the Company is providing select financial results for both GAAP and non-GAAP. Additional information, including the accounting treatment of this program and other non-GAAP measures, can be found under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results” in this press release.

Three Months EndedNine Months Ended
September 30,September 30,
$ in millions2023202220232022
GAAPNon-GAAPGAAPNon-GAAPGAAPNon-GAAPGAAPNon-GAAP
Pump Shipments
United States16,842 N/A20,394 N/A52,809 N/A59,870 N/A
Outside United States7,989 N/A12,113 N/A24,571 N/A32,846 N/A
Total Worldwide24,831 N/A32,507 N/A77,380 N/A92,716 N/A
Sales
United States$130.2 $138.5 $146.0 $146.6 $404.0 $416.5 $423.0 $423.6 
Outside United States55.4 55.4 58.5 58.5 146.9 146.9 157.7 157.7 
Total Worldwide$185.6 $193.9 $204.5 $205.1 $550.9 $563.4 $580.7 $581.3 

•Gross profit: GAAP gross profit was $89.8 million, compared to $104.4 million. GAAP gross margin was 48 percent, compared to 51 percent.

Non-GAAP gross profit(1) was $98.0 million compared to $105.0 million. Non-GAAP gross margin(1) was 51 percent for both periods.

•Operating income (loss): GAAP operating loss totaled $31.5 million, or negative 17 percent of sales, compared to operating loss of $47.5 million, or negative 23 percent of sales.

Non-GAAP operating loss(1) totaled $23.3 million, or negative 12 percent of sales, compared to $15.9 million or negative 8 percent of sales.

Adjusted EBITDA(1) was $1.5 million, or 1 percent of sales, compared to $9.9 million, or 5 percent of sales.

•Net income (loss): GAAP net loss(1) was $33.0 million, compared to net loss of $49.0 million.

Non-GAAP net loss(1) was $24.7 million compared to $17.4 million.

See tables for additional financial information.

2023 Financial Guidance

“We are reaffirming our U.S. guidance, which is largely based on strong t:slim X2 renewal purchases and supply ordering trends. Our adjusted baseline expectations outside the U.S. factors in new disruption reported by our distribution partners in key markets and relates to the timing and process for new product launches,” said Leigh Vosseller, executive vice president and chief financial officer. “We continue to yield positive results from our cost saving initiatives, which is reflected in our reaffirmed margin expectations, as we focus on executing against our growth opportunity with efficiency and discipline.”

2
Exhibit 99.1
For the year ending December 31, 2023, the Company is updating its 2023 financial guidance as follows:

•Non-GAAP sales(1) are estimated to be at least $765 million.
▪Sales inside the United States of at least $575 million.
▪Sales outside the United States of at least $190 million.
•Non-GAAP gross margin(1) is estimated to be approximately 51 percent.
•Adjusted EBITDA margin(1) is estimated to be at least breakeven as a percent of sales.
▪Includes approximately 3 percent from the impact of operating costs associated with the acquisitions of Capillary Biomedical and AMF Medical.
•Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $110 million. This includes:
▪Approximately $95 million non-cash, stock-based compensation expense.
▪Approximately $15 million depreciation and amortization expense.
(1) A reconciliation of non-GAAP financial measures to their closest GAAP equivalent and additional information can be found in Table E and under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results.”

Non-GAAP Financial Measures

Certain non-GAAP financial measures are presented in this press release to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important operating performance indicators because they exclude items that are unrelated to, and may not be indicative of, the Company’s core operating results. These non-GAAP financial measures, as calculated, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent, and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. To the extent the Company uses such non-GAAP financial measures in the future, they will be calculated using a consistent method from period to period. A reconciliation of each of the GAAP financial measures to the most directly comparable non-GAAP financial measures has been provided in Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release.

In particular, the accounting treatment for Tandem Choice has a high degree of complexity. In September 2022 when the program was launched, the Company began deferring a portion of sales for each eligible t:slim X2 pump shipped in the United States. Such deferrals will be recognized on a customer-by-customer basis following the commercial launch of the Company’s new hardware platform, Tandem Mobi. The timing of recognition will be based on either a) an affirmative election to participate in Tandem Choice or b) expiration of the right to participate. Notably:
•Offering the program does not impact the economics associated with how or when the initial pump sale is reimbursed.
•Customer eligibility is automatic and no election is necessary to participate in Tandem Choice at the time of a t:slim X2 purchase. An affirmative election is only required when the new hardware platform, Tandem Mobi, is commercially available, at which time any customer fees will be received and recognized as a sale.
•The expiration date of Tandem Choice is December 31, 2024.
Consistent with SEC regulations, the Company has not provided a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures in reliance on the “unreasonable efforts” exception set forth in the applicable regulations, because there is substantial uncertainty associated with predicting any future adjustments that may be made to the Company’s GAAP financial measures in calculating the non-GAAP financial measures.

Conference Call

The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To access the call by phone, please use this link (https://register.vevent.com/register/BIef8a824a5ebe4f3fbec7ba819e215d96) and you will be provided with dial-in details, including a personal pin.
3
Exhibit 99.1

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company headquartered in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The Company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com.

Tandem Diabetes Care, the Tandem logo, Control-IQ, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries.

Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2 and #TandemDiabetes.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements include statements regarding, among other things, the Company’s projected financial results and the ability to achieve other operational and commercial goals for this year, including the launch of multiple new products. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, the Company’s ability to achieve projected financial results will be impacted by market acceptance of the Company’s existing products and products under development; products marketed and sold or under development by competitors; the Company’s ability to establish and sustain operations to support international sales, including expanding into additional geographies; changes in reimbursement rates or insurance coverage for the Company’s products; the Company’s ability to meet increasing operational and infrastructure requirements from higher customer interest and a larger base of existing customers; the Company’s ability to complete the development and launch of new products when anticipated; risks associated with the regulatory approval process for new products; the potential that newer products, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, may render the Company’s products obsolete, less desirable; or may otherwise negatively impact the purchasing trends of customers; reliance on third-party relationships, such as outsourcing and supplier arrangements; global economic conditions; and other risks identified in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other documents that the Company files with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

# # #

4
Exhibit 99.1
TANDEM DIABETES CARE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
Table A
(in thousands)
(Unaudited)
September 30,December 31,
20232022
Assets
Current assets:
Cash, cash equivalents and short-term investments$498,158 $616,901 
Accounts receivable, net100,318 114,717 
Inventories143,492 111,117 
Other current assets16,176 7,241 
Total current assets758,144 849,976 
Property and equipment, net75,760 68,552 
Operating lease right-of-use assets89,434 110,626 
Other long-term assets16,571 23,631 
Total assets$939,909 $1,052,785 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable, accrued expenses and employee-related liabilities$103,950 $104,007 
Operating lease liabilities17,618 13,121 
Deferred revenue31,610 18,837 
Other current liabilities33,932 29,325 
Total current liabilities187,110 165,290 
Convertible senior notes, net - long-term284,580 283,232 
Operating lease liabilities - long-term116,012 123,524 
Deferred revenue - long-term14,089 16,874 
Other long-term liabilities24,118 23,918 
Total liabilities625,909 612,838 
Total stockholders’ equity314,000 439,947 
Total liabilities and stockholders’ equity$939,909 $1,052,785 
5
Exhibit 99.1
TANDEM DIABETES CARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Table B
(in thousands, except per share data)
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2023202220232022
Sales$185,622 $204,547 $550,922 $580,716 
Cost of sales95,869 100,122 276,527 283,252 
Gross profit89,753 104,425 274,395 297,464 
Operating expenses:
Selling, general and administrative79,328 84,104 266,752 237,989 
Research and development41,970 36,798 127,063 103,529 
Acquired in-process research and development expenses— 31,016 78,750 31,016 
Total operating expenses121,298 151,918 472,565 372,534 
Operating loss(31,545)(47,493)(198,170)(75,070)
Total other income (expense), net816 144 9,226 (1,668)
Loss before income taxes(30,729)(47,349)(188,944)(76,738)
Income tax expense2,232 1,621 3,665 2,003 
Net loss$(32,961)$(48,970)$(192,609)$(78,741)
Net loss per share - basic$(0.51)$(0.76)$(2.97)$(1.23)
Net loss per share - diluted$(0.51)$(0.76)$(2.97)$(1.23)
Weighted average shares used to compute basic and net loss per share65,117 64,236 64,834 64,066 
Weighted average shares used to compute diluted net loss per share65,117 64,237 64,834 64,067 

6
Exhibit 99.1

TANDEM DIABETES CARE, INC.
SALES BY GEOGRAPHY
Table C(1)
(Unaudited)
($'s in thousands)Three Months Ended September 30,Nine Months Ended September 30,
20232022% Change20232022% Change
United States:
Pump$66,365 $81,295 (18)%$207,180 $236,448 (12)%
Supplies and other72,093 65,339 10%209,352 187,136 12%
Deferral for Tandem Choice(8,236)(599)1,275%(12,568)(599)1,998%
Total GAAP Sales in the United States$130,222 $146,035 (11)%$403,964 $422,985 (4)%
Adjustment for Tandem Choice8,236 599 1,275%12,568 599 1,998%
Total Non-GAAP Sales in the United States$138,458 $146,634 (6)%$416,532 $423,584 (2)%
Outside the United States:
Pump$21,672 $27,385 (21)%$67,235 $75,515 (11)%
Supplies and other33,728 31,127 8%79,723 82,216 (3)%
Total Sales Outside the United States$55,400 $58,512 (5)%$146,958 $157,731 (7)%
Total GAAP Worldwide Sales$185,622 $204,547 (9)%$550,922 $580,716 (5)%
Adjustment for Tandem Choice8,236 599 1,275%12,568 599 1,998%
Total Non-GAAP Worldwide Sales$193,858 $205,146 (6)%$563,490 $581,315 (3)%

(1) A reconciliation of non-GAAP financial measures to their closest GAAP equivalent and additional information can be found in Table E and under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results.”



TANDEM DIABETES CARE, INC.
PUMP SHIPMENTS
Table D
Three Months Ended September 30,Nine Months Ended September 30,
20232022% Change20232022% Change
Pumps Shipped:
United States16,842 20,394 (17)%52,809 59,870 (12)%
Outside the United States7,989 12,113 (34)%24,571 32,846 (25)%
Total Pumps Shipped24,83132,507(24)%77,38092,716(17)%


7
Exhibit 99.1
TANDEM DIABETES CARE, INC.
Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited)
Table E
($'s in thousands)Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
GAAP sales$185,622$204,547$550,922$580,716
Adjustment for Tandem Choice (1)
8,23659912,568599
Non-GAAP sales$193,858$205,146$563,490$581,315
GAAP gross profit$89,753$104,425$274,395$297,464
Adjustment for Tandem Choice(1)
8,23659912,568599
Non-GAAP gross profit$97,989$105,024$286,963$298,063
Non-GAAP gross margin(2)
51%51%51%51%
GAAP operating loss$(31,545)$(47,493)$(198,170)$(75,070)
Acquired in-process research and development(3)
—31,01678,75031,016
Non-recurring facility consolidation costs(4)
——14,099—
Severance costs - cash and noncash——2,680—
Adjustment for Tandem Choice(1)
8,23659912,568599
Non-GAAP operating loss$(23,309)$(15,878)$(90,073)$(43,455)
Non-GAAP operating margin(2)
(12)%(8)%(16)%(7)%
GAAP net loss$(32,961)$(48,970)$(192,609)$(78,741)
Income tax expense2,2321,6213,6652,003
Interest income and other, net(5,656)(1,720)(17,305)(2,961)
Interest expense4,8401,5768,0794,629
Depreciation and amortization4,0233,50811,68410,689
Stock-based compensation expense20,74122,23664,94660,477
Acquired in-process research and development(3)
—31,01678,75031,016
Non-recurring facility consolidation costs(4)
——14,099—
Severance costs - cash and noncash——2,680—
Adjustment for Tandem Choice(1)
8,23659912,568599
Adjusted EBITDA$1,455$9,866$(13,443)$27,711
Adjusted EBITDA margin(2)
1 %5 %(2)%5 %
GAAP net loss$(32,961)$(48,970)$(192,609)$(78,741)
Acquired in-process research and development(3)
—31,01678,75031,016
Non-recurring facility consolidation costs(4)
——14,099—
Severance costs - cash and noncash——2,680—
Adjustment for Tandem Choice(1)
8,23659912,568599
Non-GAAP net loss$(24,725)$(17,355)$(84,512)$(47,126)
(1) The accounting treatment for Tandem Choice has a high degree of complexity. Additional information can be found under the heading “Non-GAAP Financial Measures.”
(2) Non-GAAP margins including non-GAAP gross margin, non-GAAP operating margin, and adjusted EBITDA margin are calculated using non-GAAP sales.
(3) Acquired in-process research and development charges representing the value of acquired in-process research and development assets with no alternative future use and acquisition related expenses recorded in connection with the acquisitions of AMF Medical SA in 2023, and Capillary BioMedical, Inc. in 2022.
(4) The Company recorded $14.1 million of facility consolidation costs related to our Vista Sorrento lease in San Diego, California.
8
v3.23.3
Cover Page Cover Page
Nov. 01, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 01, 2023
Entity Registrant Name Tandem Diabetes Care, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-36189
Entity Tax Identification Number 20-4327508
Entity Address, Address Line One 12400 High Bluff Drive
Entity Address, City or Town San Diego
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92130
City Area Code 858
Local Phone Number 366-6900
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol TNDM
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001438133
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